Dual Sensory Impairment of Vision and Hearing Clinical Trial
— LVROfficial title:
Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot
| Verified date | September 2019 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aims of the Improving Communication with Formal/Informal Caregivers among Older Adults
with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision
Rehabilitation Clinic (LVR) are:
Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. DSI)
among a clinical LVR population) in older adults (≥60 years) with English proficiency free
from moderate to severe depression or cognitive decline using the Hearing Handicap Inventory
for the Elderly (HHIE) assessment and an objective hearing evaluation.
Aim 2 To describe the perceived burden of care on primary caregiver (identified people who
assist with two or more activities of daily living. instrumental activities of daily living
(ADLs/Instrumental activities of daily living (IADLs))of individuals with dual sensory
impairment (DSI) among a clinical LVR population in older adults (≥60 years) with English
proficiency free from moderate to severe depression or cognitive decline using the Zarit
Burden Interview questionnaire and qualitative interview data analyses.
Aim 3 To determine feasibility and benefit of a pilot manualized over-the-counter hearing
intervention program on LVR patients to address communication among a DSI population using
the Zarit Burden Interview questionnaire.
3A: Describe feasibility based on completion of pilot, drop-out rate, and semi-structured
interviews 3B: Describe perceived communication improvements based on semi-structured
interviews
| Status | Completed |
| Enrollment | 168 |
| Est. completion date | September 20, 2019 |
| Est. primary completion date | September 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria- Older Adult Participants To be eligible for aims 1 & 2 of the study, older adult participants must meet all of the following criteria: - Age over 60 years. Individuals aged over 60 years at the time of recruitment are eligible for participation. - Low Vision Rehab Patient/Attendee - Fluent English Speaker - Caregiver who reports aiding in 2 or More ADLs/IADLs. - Residency. Participants must plan to reside in the local area for the pilot duration - Willingness to participate and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to adhere to the pilot protocol for the duration of the pilot (1 session for aim 1 and aim 2, 2 sessions 4-6 weeks apart for aim 3). To be eligible for aim 3 of the study, older adult participants must meet the following additional criteria: - Dual Sensory Impairment (only for aims 2 and 3) - Hearing Impairment. Participant hearing will be measured by pure tone audiometry a four-frequency test in both ears. Hearing impairment score >=25dB in better ear. Caregiver (Identified People who Assist with Two or More ADLs/IADLs) Participants To be eligible for aims 2 & 3 of the study, caregiver participants must meet the following criteria: • Assist an eligible and willing older adult pilot participant with two or more ADLs/IADLs. Exclusion Criteria: Potential candidates for enrollment who meet one or more of the following criteria are excluded from participation in the study: - Medical contraindication to use handheld amplifier. Because hearing amplifier will be the primary device used in the hearing intervention, participants with medical contraindications to hearing amplifier use are excluded. Contraindication will be determined by pilot audiologist. These may include: - Active ear infection - Atresia - Profound hearing loss beyond the limits of the device - Asymmetrical hearing loss - Central hearing loss (i.e. neurologic in origin) - Free from Vision Impairment. Participants will be excluded who have no vision impairment after refraction on acuity, visual field status and contrast sensitivity as assessed by a low vision rehabilitation clinician. - Depression. Screened with Center for Epidemiological Studies-Depression (CES-D) score =16. - No participants are excluded based on race or sex. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Low Vision Rehabilitation Clinic, Johns Hopkins | Baltimore | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of Dual Sensory Impairment | Measured by the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation (by pure tone audiometry a four-frequency test in both ears. Hearing impairment score >25dB in better ear). Total HHIE score: summation of 10 items (0, 2 or 4 points per item, total score range 0 to 40). 0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap. |
1 day | |
| Secondary | Impact of Dual Sensory Impairment on Formal/informal Caregivers by 12 Question Zarit Burden Interview Questionnaire (Range 0-48, 0-10 mild burden, 10-20 mild to moderate burden, >20 high burden) | Caregivers defined as identified people who assist with two or more ADLs/IADLs). Impact measured by a 12 item Zarit Burden Interview Questionnaire(ZBI-12) to assess burden of care. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48). 0-10: no to mild burden 10-20: mild to moderate burden >20: high burden |
1 day | |
| Secondary | Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews | Feasibility will be measured by semi-structured dyad interviews conducted with formal/informal caregiver and older adult participant pairs. Feasibility will then be determined qualitatively based on participants' response to the interview questions. | 4-6 Weeks | |
| Secondary | Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire | Impact of hearing amplifier on dyad caregiver burden will be measured with ZBI-12. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48). 0-10: no to mild burden 10-20: mild to moderate burden >20: high burden |
4-6 Weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06362213 -
Gaining Insight Into Dual Sensory Loss
|